Non-Invasive Biomarkers in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00413140
Recruitment Status : Completed
First Posted : December 19, 2006
Last Update Posted : December 19, 2006
Cystic Fibrosis Foundation Therapeutics
Information provided by:
Maastricht University Medical Center

Brief Summary:

Background Chronic airway inflammation is present in cystic fibrosis. Non-invasive inflammometry may be useful in disease management.

Objective We studied 1) the ability of fractional exhaled nitric oxide and inflammatory markers (acidity, nitrite, nitrate, hydrogen peroxide, 8-isoprostane, interferon-γ, tumor necrosis factor-α, interleukin-2,-4,-5,-10) in exhaled breath condensate, to discriminate between cystic fibrosis and control children, and, 2) the relationship of biomarkers with control and severity of cystic fibrosis.

Methods In 98 children (48 cystic fibrosis / 50 controls), condensate was collected using a glass condenser. Exhaled nitric oxide was measured using the NIOX®.

Condition or disease
Cystic Fibrosis

Study Type : Observational
Enrollment : 100 participants
Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Biomarkers in Exhaled Breath Indicate Presence, Control and Severity of Cystic Fibrosis
Study Start Date : June 2004
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

CF population

  • Children known with CF were recruited from the outpatient clinics. CF disease was defined as a combination of typical clinical features (e.g. persistent pulmonary problems, meconium ileus, failure to thrive, steatorrhoe) and an abnormal sweat test (Chloride > 60 mM). Uncontrolled CF was diagnosed by the paediatric pulmonologist based on a change in the presence or severity of respiratory symptoms in association with CF, and/or a decrease in lung function parameters compared to previous measurements during the last four weeks.

Control population

  • Control children without lung disease were recruited from the outpatient clinic of the University Hospital Maastricht. The reasons of consultation were constipation and enuresis nocturna. All children completed the ‘International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire to exclude children with any (history of) airway or allergy complaints, in order to exclude asthmatic disease

Exclusion Criteria:

For both study populations:

  • Diseases that may interfere with the results of the study (e.g. upper airway infection, heart disease, anatomic abnormalities of the airways and other chronic inflammatory diseases, such as Crohns disease and rheumatoid arthritis)
  • Mental retardation
  • Inability to perform the EBC collection procedure
  • Active smoking
  • Use of the following medication: papaverin, sodium nitroprusside, angiotensin-converting enzyme (ACE) inhibitors, oxymetazoline, L-arginine, or nitric oxide synthase (NOS) inhibitors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00413140

Catharina Hospital
Eindhoven, Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6202AZ
St Radboud Childrens Hospital
Nijmegen, Netherlands
Máxima Medical Centre
Veldhoven, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Cystic Fibrosis Foundation Therapeutics
Principal Investigator: Charlotte M Robroeks, M Maastricht University Medical Center
Study Director: Edward Dompeling, MD, PhD Maastricht University Medical Center
Study Director: Quirijn Jöbsis, MD, PhD Maastricht University Medical Center Identifier: NCT00413140     History of Changes
Other Study ID Numbers: MEC 03-228-CF
First Posted: December 19, 2006    Key Record Dates
Last Update Posted: December 19, 2006
Last Verified: November 2003

Keywords provided by Maastricht University Medical Center:
childhood disease
cystic fibrosis
exhaled breath condensate
exhaled nitric oxide
airway inflammation
non-invasive inflammatory markers

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases